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Radiation Therapy
CyberKnife + Chemotherapy for Pancreatic Cancer
Phase < 1
Waitlist Available
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medical status suitable for consideration of major pancreatic surgery
Pathologically confirmed adenocarcinoma of the pancreas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year, 5 years
Awards & highlights
Study Summary
This trial is testing CyberKnife radiosurgery in combination with chemotherapy to see if it can better treat adenocarcinoma of the pancreas.
Who is the study for?
This trial is for adults over 18 with a specific type of pancreatic cancer that could potentially be removed by surgery. They must have a life expectancy greater than 3 months, no severe other diseases, and agree to use contraception. Those with recent cancers besides pancreatic adenocarcinoma or who've had upper abdomen radiation can't join.Check my eligibility
What is being tested?
The study tests combining CyberKnife (a precise form of radiation therapy) with Gemcitabine chemotherapy in patients whose pancreatic cancer might be surgically removed. It aims to see if this combination improves outcomes before surgery.See study design
What are the potential side effects?
CyberKnife treatment may cause fatigue, skin reactions at the treatment site, and nausea. Gemcitabine can lead to side effects like flu-like symptoms, low blood cell counts increasing infection risk, bleeding or bruising easily, and liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am medically fit for major pancreatic surgery.
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My diagnosis is pancreatic adenocarcinoma.
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I am older than 18 years.
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My blood vessels near the pancreas are not significantly blocked or can be fixed.
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My condition might be treatable with surgery according to my scans.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My cancer has not spread to organs near the pancreas.
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My cancer has not spread to the area near my celiac trunk and involves less than half of its surrounding area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 1 year, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
percentage of subjects who successfully undergo pancreaticoduodenectomy
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival
Quality of Life
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AExperimental Treatment2 Interventions
Chemotherapy:
Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle
Radiation:
25 Gy over 5 fractions
Surgery:
surgical resection of pancreas
treatment plan:
1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
The Cooper Health SystemLead Sponsor
76 Previous Clinical Trials
33,098 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood and organs are functioning well.I have not had cancer other than pancreatic cancer in the last 5 years.I am medically fit for major pancreatic surgery.I have had radiation therapy to my upper abdomen.My diagnosis is pancreatic adenocarcinoma.I am older than 18 years.My blood vessels near the pancreas are not significantly blocked or can be fixed.My condition might be treatable with surgery according to my scans.My pancreatic cancer has spread beyond the pancreas.You are expected to live for more than 3 months.I cannot have an MRI with contrast for treatment planning.The TVI of the SMA Abutment should be at least 180 degrees.I am not taking any other cancer treatment while on this trial.I can take care of myself and am up and about more than 50% of my waking hours.My cancer has not spread to organs near the pancreas.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a serious health condition that prevents me from having surgery.My pancreatic cancer cannot be removed with surgery.My cancer has not spread to the area near my celiac trunk and involves less than half of its surrounding area.
Research Study Groups:
This trial has the following groups:- Group 1: A
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What illnesses can be treated effectively with Stereotactic Radiosurgery?
"Stereotactic Radiosurgery is typically used to treat small cell lung cancer (sclc). This technique also has the ability to manage certain cancers in areas such as head and neck, pancreas, and cervix."
Answered by AI
Is enrollment open presently for this clinical trial?
"This clinical trial, which debuted on January 1st 2013 and last edited on March 8th 2016, is not seeking new participants at this time. However, according to the database hosted by clinicaltrials.gov there are 1809 other medical studies with open recruitment opportunities right now."
Answered by AI
Are there any precedent cases where Stereotactic Radiosurgery has been explored experimentally?
"At the moment, 446 active trials for Stereotactic Radiosurgery are underway with 134 in their final testing stage. The bulk of these tests take place in Melbourne, Victoria but there is a total 24594 sites hosting studies related to this procedure."
Answered by AI
How many participants have been enrolled in this clinical trial thus far?
"This clinical trial is not currently recruiting patients. It was initially posted in 2013 and updated last in 2016, so it has been inactive for some time. There are 1363 trials actively looking for participants with pancreatic cancer and 446 seeking enrollees for Stereotactic Radiosurgery if you're searching for alternative studies to join."
Answered by AI
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